|Publication number||US7674265 B2|
|Application number||US 10/422,221|
|Publication date||Mar 9, 2010|
|Filing date||Apr 24, 2003|
|Priority date||Apr 24, 2003|
|Also published as||CA2523257A1, EP1622516A2, US8460296, US20040215197, US20100152791, WO2004096055A2, WO2004096055A3|
|Publication number||10422221, 422221, US 7674265 B2, US 7674265B2, US-B2-7674265, US7674265 B2, US7674265B2|
|Inventors||Maurice M. Smith, Roy Lim, Thomas E. Roehm, III|
|Original Assignee||Warsaw Orthopedic, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (26), Referenced by (10), Classifications (5), Legal Events (4)|
|External Links: USPTO, USPTO Assignment, Espacenet|
Surgery for a patient can be painful and traumatic, particularly in the affected area of the patient's body. For example, the dissection and retraction required to access the surgical site in the patient can cause trauma to the dissected and retracted tissue as well as to the surrounding tissue. Tissue dissection and retraction can be required to insert instruments to a surgical site. To accommodate insertion, sufficient dissection and/or retraction of muscle tissue, nerve tissue, vasculature tissue and other tissue must be made to allow passage of the instrument therethrough.
Surgical instruments can include sharp elements which can cut or cause trauma to tissue in the approach to and adjacent the surgical site. Tissue dissection and retraction may be increased to avoid contact between the instrument and the tissue in the approach to the surgical site. Additionally, delicate anatomical structures may be present at or near the surgical site. Additional instruments or other precautions may be required to protect such tissue that limit or inhibit access to the surgical site.
For spinal surgical procedures, preparation of an endplate for ensuing fusion can require difficult maneuvering and gesturing of surgical instruments, such as curettes or scrapers, to cut or penetrate the bony material of the endplate. Sufficient time and effort during the surgery must be devoted to the use such instruments to obtain the desired result.
There remains a need for instruments and methods that can be employed for preparing a surgical site that minimize tissue dissection and retraction and exposure of the anatomical structures at the surgical site to sharp elements of the instruments. There further remains a need for instruments and methods that can be efficiently and effectively employed for preparing vertebral endplates for ensuing fusion. The present invention is directed to meeting these needs, among others.
A treatment instrument is provided that includes a treatment member movable between deployed and undeployed positions. In the undeployed position, the at least one treatment member is positionable to a surgical site without exposing the anatomical structures to sharp edges of the treatment member. In the deployed position, the treatment member includes at least one treatment portion adapted to treat a vertebral endplate positioned adjacent the treatment member. The treatment of the vertebral endplate includes penetrating, crushing and/or removing bone material to induce bleeding to promote subsequent fusion of adjacent vertebrae in a spinal fusion procedure.
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any such alterations and further modifications in the illustrated device and any such further applications of the principles of the invention as illustrated therein are contemplated as would normally occur to one skilled in the art to which the invention relates.
Treatment system 12 includes a plurality of first treatment members 26 and a plurality of second treatment member 28. Treatment members 26 each include a plurality of treatment portions 27 extending from one side thereof. Treatment member 28 includes a plurality of treatment portions 29 extending from one side thereof in a direction opposite treatment portions 27. In the illustrated embodiment, treatment members 26 include treatment portions 27 oriented in the same direction and are separated from one another by a treatment member 28 that includes treatment portions 29 oriented in the direction opposite the orientation of treatment portions 27. Other embodiments contemplate that two or more of the treatment members 26 and/or treatment members 28 are positioned directly adjacent one another. Still other embodiments contemplate a treatment instrument 10 with treatment portions that extend in only one direction when the treatment members are deployed.
In the illustrated embodiment, treatment portions 27, 29 provide a serrated surface along the respective treatment member 26, 28. The treatment portions 27, 29 include a plurality of pyramidally shaped spikes having a sharpened outer end to penetrate bone material of the vertebral endplate when deployed. Other shapes and forms are also contemplated for treatment portions 27, 29. For example, treatment portions 27, 29 could include a plurality or series of elongated blades or sharp edges that extend transversely to a longitudinal axis 11 of treatment instrument 10. In another example, treatment portions 27, 29 include one or more sharp edges that extend along the longitudinal axis 11 of treatment instrument 10. Still other embodiments contemplate treatment portions 27, 29 in the form of spikes, barbs, or teeth with sharp ends. It is also contemplated that treatment portions 27, 29 can include blunt ends that crush the adjacent bony structure when deployed.
In the undeployed position of
Treatment portions 27, 29 can at least partially penetrate, crush, or otherwise form openings in the bony material of the vertebral endplates when deployed. This promotes bleeding of the vertebral endplates and facilitates bone growth and implant incorporation in interbody fusion procedures. Treatment portions 27, 29 can be withdrawn and redeployed as needed to provide the desired penetration and/or bleeding of the endplates. It is further contemplated that treatment instrument 10 can be manipulated with treatment portions 27, 29 deployed to provide further endplate treatment. For example, treatment instrument 10 can be moved in the proximal-distal directions, laterally, and/or rotated in the disc space in small strokes with treatment portions 27, 29 deployed. When the desired treatment has been obtained, treatment portions 27, 29 can be withdrawn into mounting portion 13, allowing withdrawal of treatment system 12 from the disc space and the patient's body without exposing tissue, nerves and other anatomical structures to treatment portions 27, 29.
Body portion 100 includes a proximal slot 106 orthogonally oriented to longitudinal axis 101. Body portion 100 further includes a proximal passage 108 and a distal passage 110. Passages 108, 110 are inclined relative to longitudinal axis 101 so that passage 108 includes a distal end 109 and a proximal end 111, and passage 110 includes a distal end 112 and a proximal end 113. Distal ends 109, 112 are offset from longitudinal axis 101 and positioned adjacent treatment portions 27, and proximal ends 111, 113 are offset from longitudinal axis 101 and positioned adjacent second side 103. Treatment member 28 similarly includes a body portion 100 including a proximal slot 106, a proximal passage 108, and a distal passage 110, as shown in
Referring further to
Flange member 20 includes a side opening 34 extending from a distal end wall 51 of end member 24 distally along a portion of the length of flange member 20. Similarly, flange member 22 includes a side opening 36 extending from distal end wall 51 of end member 24 along a portion of the length of flange member 22. A distal guide pin 30 extends between and is secured in holes 31, 35 adjacent the distal end noses 40, 44 of flange members 20, 22. A proximal guide pin 32 extends between and is secured in holes 33, 37 located about mid-length along flange members 20, 22 and distally of side openings 34, 36. Flange member 20 includes distal end nose 40 having a blunt rounded shape, and flange member 22 includes distal end nose 44 having a blunt rounded shape. The blunt rounded shape facilitates insertion through tissue and into the space between adjacent vertebrae.
As shown in
When assembled, treatment members 26, 28 are coupled to coupling assembly 70 and positioned between and movable relative to flange members 20, 22 by movement of actuating member 60. Treatment members 26, 28 are movably mounted to flange members 20, 22 with distal guide pin 30 extending through distal passages 110, and proximal guide pin 32 extending through proximal passages 108. Linkage member 76 of coupling assembly 70 extends through proximal slots 106, and linkage plates 72, 74 are received in respective ones of the side openings 34, 36. Drive member 71 of coupling assembly 70 is positioned distally of distal end wall 51 of end member 24 between flange members 20, 22. Drive member 71 is larger than the opening of passage 57 at the distal end of shaft 50, and can contact distal end wall 51 to limit proximal movement of coupling assembly 70 and thus actuating member 60 relative to mounting member 15.
When treatment members 26, 28 are in their undeployed position, proximal member 71 is adjacent end wall 51, guide pin 32 is located adjacent distal ends 112 of distal passages 110 and distal ends 109 of proximal passages 108. Linkage member 76 is located adjacent the upper end of proximal slots 106. In the undeployed position, treatment members 26, 28 are retracted so that treatment portions 27 are recessed at or below the upper ends 41, 45 of flange members 20, 22, and treatment portions 29 are recessed at or below the lower ends 43, 46 of flange members 20, 22, as shown in
When deployed, actuating member 60 is moved distally relative to mounting member 15, thereby advancing coupling assembly 70 distally between flange members 20, 22. This distal movement advances treatment members 26, 28 along guide pins 30, 32 until guide pin 32 is located adjacent proximal ends 113 of distal passages 110 and proximal ends 111 of proximal passages 108. The inclination of passages 108, 110 relative to longitudinal axis 101 of treatment members 26, 28 causes treatment members 26, 28 to move upwardly and downwardly, respectively, advancing treatment portions 27, 29 beyond the upper ends 41, 45 and lower ends 43, 46 of flange members 20, 22. Linkage plates 72, 74 are simultaneously advanced distally in side openings 34, 36.
As shown in
The mounting arrangement between mounting portion 13 and treatment members 26, 28 facilitates the application of sufficient force to treatment members 26, 28 so that treatment portions 27, 29 can penetrate and/or crush the adjacent bony structure when deployed. Guide pins 30, 32 provide multiple support locations in the passages 110, 108 of treatment members 26, 28 to maintain parallel movement of the treatment members 26, 28 relative to longitudinal axis 11 throughout the range of motion between deployed and undeployed positions.
Distal movement of actuating member 60 in mounting member 15 can be limited by any one or combination of contact of the guide pins 30, 32 with the proximal ends of passages 110, 108; contact of linkage member 76 with the end of slot 106 opposite the respective treatment portions 27, 29; contact of linkage plates 72, 74 with the distal ends of side opening 34, 36; with an arrangement between the proximal ends of mounting member 15 and actuating member 60; or with the handle assembly 16.
Referring now to
Extensions 54, 64 contact one another to resist inner shaft 66 from rotating within passage 57. Proximal boss 62 can include a first notch 68 formed in a first side thereof and a second opposing notch (not shown) in the opposite side. Proximal boss 52 can include a first notch 58 formed in a first side thereof and a second opposing notch (not shown) in the opposite side. As discussed further below, notches 58, 68 facilitate attachment of handle assembly 16 to bosses 52, 62.
It is contemplated that the vertebral endplate treatment instruments discussed herein can be used in minimally invasive surgical techniques where the disc space is accessed through a micro-incision, a sleeve, or one or more retractors that provide a protected passageway to the disc space. The treatment instruments also have application in open surgical techniques where skin and tissue are incised and retracted to expose the surgical site. The treatment instruments can be useful in posterior approaches to a spinal disc space where tissue, nerves, and the posterior vertebral elements hinder access to the disc space. Applications in other approaches, including anterior, anterior-oblique, lateral, and postero-lateral approaches are also contemplate. The treatment instruments also have application in procedures that access any region of the spine, including the cervical, thoracic, lumbar and sacral regions.
Referring further to
Locking member 150 includes a slotted receptacle 162 that receives a pin (not shown) coupled to movable shaft 148 to movably secure locking member 150 thereto. Similarly, locking member 152 includes a slotted receptacle 164 to receive a pin 166 coupled to fixed shaft 146 to movably secure locking member 150 thereto. In the locked position of locking members 150, 152 shown in
A torque handle 142 can be provided that extends laterally from fixed shaft 146. Torque handle 142 can be grasped by the surgeon to facilitate insertion and withdrawal of the distal end of instrument 10 from the operative site. Torque handle 142 can also assist in moving instrument 10 proximally, distally, and/or rotationally about axis 11 with treatment members 26, 28 in the deployed condition to provide further treatment of the endplates.
While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character. All changes and modifications that come within the spirit of the invention are desired to be protected.
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|Cooperative Classification||A61B17/1671, A61B17/1659|
|Apr 24, 2003||AS||Assignment|
Owner name: SDGI HOLDINGS, INC., DELAWARE
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SMITH, MAURICE M.;LIM, ROY;ROEHM, III, THOMAS E.;REEL/FRAME:014004/0487;SIGNING DATES FROM 20030331 TO 20030404
Owner name: SDGI HOLDINGS, INC.,DELAWARE
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SMITH, MAURICE M.;LIM, ROY;ROEHM, III, THOMAS E.;SIGNINGDATES FROM 20030331 TO 20030404;REEL/FRAME:014004/0487
|Dec 1, 2006||AS||Assignment|
Owner name: WARSAW ORTHOPEDIC, INC.,INDIANA
Free format text: MERGER;ASSIGNOR:SDGI HOLDINGS, INC.;REEL/FRAME:018573/0086
Effective date: 20061201
|Mar 14, 2013||FPAY||Fee payment|
Year of fee payment: 4
|Oct 7, 2014||AS||Assignment|
Owner name: WARSAW ORTHOPEDIC, INC, INDIANA
Free format text: CORRECTIVE ASSIGNMENT TO CORRECT T0 REMOVE APPLICATION NUMBER PREVIOUSLY RECORDED AT REEL: 018573 FRAME: 0086. ASSIGNOR(S) HEREBY CONFIRMS THE MERGER;ASSIGNOR:SDGI HOLDINGS, INC.;REEL/FRAME:033904/0891
Effective date: 20061201